FDA Announcements on Tobacco Products and What They Mean for Public Health

April 12, 2018|11:07 a.m.| ASTHO Staff

FDA’s Steps Toward Broad Regulation of
Tobacco Products

In March,
FDA Commissioner Scott Gottlieb announced three separate advanced notices of
proposed rulemaking (ANPRMs) reducing
nicotine levels in combustible cigarettes, regulating
flavor in tobacco products, and adopting
a different regulatory policy concerning premium cigars. These announcements,
which ask the public to provide scientific research, data, and other
information on the population health impacts of each potential tobacco policy
by June, signal that the FDA’s Center for Tobacco Products may, in the future,
move to implement new tobacco product regulations under the authority given to
it by 2009’s Family
Smoking Prevention and Tobacco Control Act.

This trio of
rulemaking notices from FDA is the first in a series of steps in the plan that
Gottlieb announced
in July 2017 to fundamentally change how FDA regulates products containing
nicotine. In that announcement, Gottlieb and Mitch Zeller, director of FDA’s
Center for Tobacco Products, described their intentions to reduce the use and
initiation of combustible cigarettes and reevaluate how FDA regulates
e-cigarettes and other nicotine-containing products that may represent a lesser
health risk to adult consumers. The language in these recent rulemaking notices
sheds additional light on how FDA may eventually alter the landscape on what
tobacco products can be produced and sold in the United States. However, while
these notices and comment periods are the first steps in a comprehensive and
transparent regulatory process, it is worth noting that an ANPRM does not
compel FDA to implement any tobacco product regulation by any specific
deadline.

ASTHO
reviewed the rulemaking notices from a population health perspective, looking
specifically for instances where information about states’ efforts can help
inform the FDA’s regulatory activities. Keep reading for a summary of these
insights below.

Opportunities for States

There is
reason for public health stakeholders to be encouraged by, but also critically
attentive to, this series of announcements. Since any of the rules resulting
from FDA’s notices would impact how tobacco products can be manufactured,
marketed, and/or sold across the country, state health departments and other
public health stakeholders are encouraged to submit comments on these
proposals. Due to their own experiences regulating tobacco products, state
health agencies have a wealth of information that can be used to inform the
FDA’s regulatory efforts. This input will help ensure that any forthcoming
regulatory decisions by FDA are based on strong evidence in the interest of
promoting public health.

This ANPRM
is seeking comments and data on many topics related to a potential product
standard for nicotine in cigarettes. Establishing a maximum nicotine level in
cigarettes to make them non-addictive or minimally addictive would almost
certainly have significant population health benefits by discouraging cigarette
use. A simulation model published by FDA
researchers in the New England Journal of
Medicine projects that a median of 13 million smokers would stop smoking
combustible cigarettes within five years of them becoming non-addictive and, that
by 2060, approximately 1.6 percent of American adults would smoke combustible
cigarettes if no other policies were changed from the present. This projection
represents a significantly reduced death, disease, and economic burden
resulting from all tobacco use in the United States. Comment period closes: June 14

This ANPRM
is calling on stakeholders to share data and information that can inform FDA’s
process for examining the role that flavors, including menthol, play in
initiation, use, and cessation of tobacco products. Several different tobacco
flavoring regulations could have a positive public health impact, as well. Recent
research has confirmed that candy and fruit flavors make e-cigarettes more appealing
to youth. Menthol cigarettes continue to be smoked
disproportionately by young people and African Americans, contributing to
health disparities resulting from tobacco use. Forbidding these flavorings,
preventing products that contain them from being advertised, and/or making it
harder for youth to access these products would likely reduce nicotine
addiction, the initiation of tobacco products, and the disparity gap between
non-smoking and smoking populations.

This ANPRM
recognizes that in non-combustible products, like e-cigarettes, it is possible
for the flavors to do both harm and good. For example, e-cigarette flavors may
also encourage adults to switch from combustible tobacco products to
e-cigarettes in the interest of harm reduction. A National Academy of Sciences,
Engineering, and Medicine systematic
literature review found that e-cigarettes have a mixed
impact on population health. The consequences of making flavored e-cigarette
products available to adult consumers and appealing to adult combustible
tobacco product users must be considered alongside the health impacts of these
products appealing to youth. Any positive impacts tied to encouraging adult
cigarette smokers to switch to e-cigarette products could be outweighed by the
number of young people that could become addicted to nicotine. Comment period closes: June 19

In 2016, FDA
brought additional tobacco products, including all cigars, under the agency’s
oversight to help better protect Americans from the dangers of tobacco use.
This ANPRM is seeking comments and information related to the patterns of use
and resulting public health impacts from products commonly referred to as
“premium cigars.” There is reason for the public health community to be
skeptical, however. This ANPRM could potentially result in a rollback of
existing cigar regulations. For example, FDA could decide that written health
warnings are no longer required on the packaging of premium cigars. Because no
definition of premium cigar is provided, the public cannot be assured at this
time that the categorization would exclude all flavored and relatively affordable
cigar products used
by youth and more frequently preferred by racial and ethnic minorities.

It is
important to note that, in some states, premium cigars are already incorporated
into the tobacco regulatory framework. States like Maine define
premium cigars based on weight, while Minnesota’s definition includes
a minimum price of two dollars. Also, just this year, the Colorado Senate
passed a measure to define
premium cigars, which emphasizes the handmade nature of premium products. These
definitions have significant implications for the administration,
implementation, and enforcement of tobacco control policies that can be shared
with the FDA. Comment period closes: June 25